Senior Manager, Software Device Quality

Role: Senior Manager, Software Device Quality, overseeing quality assurance for software medical devices and combination products throughout their lifecycle. Responsibilities: lead design controls, risk management (ISO 14971), change control, verification/validation, maintain design history and technical files, support global regulatory submissions, ensure compliance with standards like ISO 13485, MDSAP, MDR, and participate in audits and inspections. Manage quality issues related to complaints, CAPA, deviations, and vigilance. Requirements: Bachelor's in Engineering or related field; 7+ years in QA/Engineering within medical devices or combination products; strong knowledge of global regulations and standards; experience with regulatory submissions, external manufacturing, and root cause investigations. Preferred: advanced degree, experience in pharma/biotech, software medical device expertise, auditor certification. HighValue: focus on software medical devices, lifecycle management, compliance with international standards, global regulatory support, and cross-functional collaboration. WorkSetup: based in Lexington, MA; full-time, exempt.